Job title: Senior RA engineer

Department : RA

Report to : RA supervisor

Summary :

Familiar with the respiratory products, skilled in the respiratory standards and regulations and present as the leadership in the regulatory affairs in the respiratory products development and registration.

Dutes and responsibility :

Owns the regulatory and standards breakdown regarding the respiratory products

Owns the lab test for the active medical devices regarding the respiratory products and support for the design team with the outsourced lab test for EMC, safety and function.

Owens the responsibility to initiate the clinical trial protocol and coordinate with the CRO or qualified medical agency to do the clinical study

Owns the responsibility for the products registration both for regional or national NMPA and facilitate the registration process regarding the activities with respect the license

Owns the technical review for the respiratory products with regarding the regulatory affairs, champion as the leadership in the regulatory compliance

Facilitate the international certification regarding the respiratory products and owns the interface with the international customers regarding the RA registration activities.

Approve the design phase exit per the regulatory requirements

Maintain the NMPA certification and international certification and take action per the certification renew, certification change etc. 

Supervisory responsibility :

There is no supervisory responsibility for this job.

Qualification :

Bachelor degree or advanced degree in engineering, mechanical, biomedical or related discipline with at least 5 yrs experience in regulatory affairs

Experience in clinical study are preferred

Have the capability to communicate with the regional and national NMPA

Demonstrated experience in the respiratory products registration

Demonstrated in the active medical regulatory and standards and skillful in the standards with respect to the respiratory products.

Physical demands and work environment :

Occasional required to stand

Occasional required to walk

Frequently required to sit

Frequently required to trip

Frequently required to talk and hear

職位描述

職位名稱：高級RA工程師

部門：RA

向RA主管報告

總結：

熟悉呼吸產品，精通呼吸標準和法規，並在呼吸產品開發和註冊的法規事務中處於領導地位。

職責和責任：

負責有關呼吸產品的法規和標準分類

負責有關呼吸產品的有源醫療設備的實驗室測試，並通過外包的EMC，安全和功能實驗室測試為設計團隊提供支持。

負責啟動臨床試驗方案並與CRO或合格的醫療機構協調以進行臨床研究

負責地區或國家NMPA的產品註冊，並促進與許可證相關的活動的註冊流程

負責有關法規事務的呼吸產品技術審查，帶領團隊工作符合法規要求

促進有關呼吸產品的國際認證，與國際客戶溝通有關RA註冊活動。

根據法規要求批准設計階段輸出

保持NMPA認證和國際認證，並根據認證更新，認證變更等採取措施。

監督職責：

這項工作沒有監督責任。

資歷：

工程，機械，生物醫學或相關學科的學士學位或高級學位，至少有5年法規事務經驗

有臨床研究經驗者優先

有能力與地區和國家NMPA進行溝通

呼吸產品註冊方面的經驗

在有關呼吸產品的有效醫療法規和標準中具有熟練技能。